BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 10405075 · Received August 13, 2020

    Report

    Report Number
    9616656-2020-00782
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A PHOTO OF A SHELF CARTON FROM LOT # 9240206 AND A VIDEO OF A PEN NEEDLE ATTACHED TO A BASAGLAR PEN. CUSTOMER STATES THAT WHEN THE FLOW TEST IS PERFORMED, SOME NEEDLES DO NOT COME OUT OF THE LIQUID, THEY ARE TOTALLY CLOGGED. THE PHOTO AND VIDEO WERE EXAMINED AND EXHIBITED THE PEN NOT BEING ABLE TO FUNCTION PROPERLY. IT IS NOT CLEAR IF THERE IS AN ISSUE WITH THE PEN NEEDLE OR WITH THE PEN. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE PN 32G 4MM 5B XTW EASYFLOW LA WAS UNABLE TO DELIVER INSULIN/MEDICATION. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER "RECENTLY STARTED USING INSULIN AND WHEN THE FLOW TEST IS PERFORMED, SOME NEEDLES DO NOT COME OUT OF THE LIQUID, THEY ARE TOTALLY CLOGGED, HE INFORMED THAT HE DOES NOT REUSE AND ROTATES. THE DIVERSION HAS HAPPENED WITH 4 NEEDLES SO FAR."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE PN 32 G 4 MM 5B XTW EASYFLOW LA WAS UNABLE TO DELIVER INSULIN/MEDICATION. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER "RECENTLY STARTED USING INSULIN AND WHEN THE FLOW TEST IS PERFORMED, SOME NEEDLES DO NOT COME OUT OF THE LIQUID, THEY ARE TOTALLY CLOGGED, HE INFORMED THAT HE DOES NOT REUSE AND ROTATES. THE DIVERSION HAS HAPPENED WITH 4 NEEDLES SO FAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869713 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 9240206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other